by Holly Fernandez Lynch, JD, MBioethics, Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the US Public Health Service Syphilis Study at Tuskegee, conducted by US government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, it has significant flaws—including its potential to burden important research, lag behind developments in how research is conducted, overprotect some subjects and inadequately protect others, and generate inconsistent results.
A new book from the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, titled Human Subjects Research Regulation: Perspectives on the Future, documents some of the issues that persist with the current system of research regulation. Invigorated by the US government’s first steps toward change in over twenty years, Human Subjects Research Regulation, which was co-edited by myself and the Center’s faculty director I. Glenn Cohen, JD, brings together the leading thinkers in the fields of ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protections.
The edited volume stems from the Petrie-Flom Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the US ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.